The meaningful use incentive program has stimulated electronic health record adoption in the United States -- but confusing, conflicting proposals to change and delay the program's next stages lead many to wonder if meaningful use needs to be fixed.

The release of this data coincided with a groundswell of both confusion and frustration aimed at conflicting proposed rules from the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid Services (CMS) – along with numerous reports suggesting that many healthcare organizations, in their rush to implement EHR systems, had violated the Hippocratic oath.

EHR Vendors, Providers Equally Unprepared for Stage 2

Under the HITECH Act, hospitals and eligible providers who are eligible for the Medicare EHR Incentive Program but fail to begin the attestation process (for either stage 1 or 2) by the end of the 2014 fiscal year face financial penalties starting in 2015. Rules differ for the Medicaid EHR Incentive Program.

One explanation: EHR vendors lag in stage 2 upgrades. Some told customers that their 2014 Certified EHR Technology (CEHRT) – that is, the EHR version needed for stage 2 – wouldn't be ready in time for hospitals to complete the 90-day stage 2 attestation reporting period by Sept. 30, the final day of the 2014 federal fiscal year. In other words, the product that got them to stage 1 wouldn't be able to get them to stage 2, so they would face meaningful use penalties.

Confused? You're not alone. So is Dr. John Halamka, CIO of Beth Israel Deaconess Medical Center in Boston and co-chair of ONC's Health IT Standards Committee. He arguably knows meaningful use better than anyone. While Halamka says the proposed rule "wisely" and "elegantly" adds flexibility to meaningful use, he adds that layering fixes on meaningful use "creates too much complexity" and further suggests that the program needs consolidation and simplification.

Frustrated? You're not alone, either. So it Tate, who goes so far as to say that the proposed rule – open to public comment until July 21 and subsequently revised – strikes at the credibility of the whole meaningful use program. "Out of the blue, they said, 'Even though you've been planning for stage 2, you may not have to meet it, but we won't tell you for three months,'" Tate says. "Nobody knows, and we won't know until August or September."

Meaningful Use Too Much Time, Money and Effort?

Not everyone will be waiting patiently. Some providers plan to take the meaningful use money and run, accepting that the noncompliance penalty is less than it will cost to attest for stage 2.

This is the case because meaningful use frontloaded its incentives. Under the Medicare program, for example, eligible providers attesting for stage 1 in 2011, 2012 and 2013 have received $38,000 of the $44,000 for which they are eligible. Hospitals likewise attesting all three years have received close to 90 percent of what they're due.

For such small incentives, it's a lot of effort. As it is, meaningful use stage 1 changed the way hospitals implement EHR, with functionality previously saved for the end of the process moved forward if it happens to be a meaningful use requirement. (Examples include computerized physician order entry, or CPOE, and clinical care guidelines.)

Stage 2 brings additional challenges. As a Government Accountability Office (GAO) report detailed earlier this year, several optional (or "menu") requirements in stage 1 become mandatory (or "core") in stage 2 – transition of care documentation, public health data submission (syndromic and reportable lab results), medication reconciliation and providing patients with electronic copies of their health information. Many of these issues point to an unmet need for better infrastructure, Tate says.

It shouldn't be surprising, then that many providers feel buyers' remorse, with 40 percent indifferent toward or dissatisfied with their EHR systems. Meaningful use isn't wholly to blame here – poor usability, a lack of interoperability and inadequate health information exchange capabilities all leave providers frustrated with EHR systems – but it has led some organizations to consider replacing an EHR system in order to attest for stage 2. (Word to the wise: It's harder than you think.)

It shouldn't be surprising that meaningful use hasn't done enough to improve healthcare IT, according to the government advisory group known as JASON. The headlong plunge into EHR adoption overemphasizes meaningful use at the expense of innovation and the "creation of a truly interoperable health data infrastructure," the group says in a recent report funded by the Agency for Healthcare Research and Quality (AHRQ).

According to RAND, that's because meaningful use encourages the use of existing EHR technologies that "are not designed to talk to each other." (The consultancy comes down particularly hard on market leader Epic Systems, which sells client-based EHR systems so customizable that facilities in the same system often cannot share data.)

It shouldn't be surprising that "those with an interest in the common good," as Tate calls them, have called for a meaningful use reboot that emphasizes standards and outcomes and puts the brakes on new requirements so providers can focus on infrastructure, quality reporting and interoperability.

Meaningful Use May Get Worse Before It Gets Better

These circumstances alone suggest that things could get worse before they get better. Additional factors tip the scale even further.

In February, ONC released a proposed rule for a 2015 voluntary EHR certification program. "A two- to three-year regulatory is sub-optimal," the agency writes in its proposed rule, having "created cycles of significant peaks and valleys from a health IT development standpoint." What's more, the program would act as a bridge of sorts to the 2017 EHR certification requirements.

In theory, 2015 voluntary EHR certification represents ONC's attempt at a flexible EHR strategy, especially given the changes to the meaningful use timeline announced at the end of 2013. To that end, it introduces the possibility for "gap certification" to cover anything that remains unchanged from the 2014 to 2015 requirements. (At a glance, these criteria consist largely of those with the lowest software development cost.)

In practice, Tate says, it's just more confusion:

Why would a vendor rush to pursue voluntary 2015 EHR certification if, under the proposed meaningful use recertification rule, 2011 EHR certification will be OK for 2014?

Will those 40 percent of providers in the market for a new EHR system look less favorably on an EHR vendor that hasn't completed a voluntary certification program?

Without knowing what will change between the 2015 and 2017 certification criteria, what's the point of the voluntary certification?

GAO sees two problems here. From a technical standpoint, organizations historically collected and calculated CQMs by hand. Only later was the "chart abstraction process" modified for EHR systems. Not all data needed for reporting quality measures is collected by EHR systems; as a result, it's not part of the typical clinicians' everyday workflow.

"Until HHS establishes and implements a comprehensive strategy to ensure the reliability of CQMs collected using certified EHRs, it will be unclear whether the department's plans are sufficient to address the concerns," the GAO report says. "Therefore it will be uncertain when the CQM data can be reliably used to help assess provider performance, improve quality and adjust provider payments."

That points to the second, and arguably larger, concern – early returns suggest that attesting for meaningful use doesn't improve care quality on its own. The GAO points out that meaningful use cites 26 specific strategic goals related to EHR adoption but not a single specific goal pertaining to improving quality, efficiency and patient safety.

To be fair, ONC and CMS have long said that improving quality through the use of shared health data is the focal point of stage 3 (with stage 1 focused on collecting data and stage 2 on sharing that data). "However," GAO writes, "establishing outcome-oriented performance measures before results are expected is a valuable practice to ensure that the agencies can make program adjustments as needed and are prepared to monitor outcomes and to establish baseline values, which can be useful for developing performance targets and assessing progress toward goals."

It's little wonder, then, that accountable care organizations avoid EHR vendors, having found third parties better served to meet their various care management, reporting and risk stratification needs. If the ACO model represents the future of care delivery in the United States – with groups of providers embracing more coordinated care and leaving the fee-for-service world behind – will the majority of today's hospitals and eligible providers, and their inadequate but nonetheless certified EHR systems, be left behind?

Restructured ONC Ready for Business

The five-plus years since the HITECH Act, an eternity in the technology world, represent little more than the blink of an eye for government. As Tate puts it, building the EHR Incentive Program and writing the meaningful use regulations embodied an "entrepreneurial spirit" of sorts.

Now, though, it's time to grow up. The ONC gets this; in Tate's words, its "collapsed bureaucratic structure," announced in June in response to the expiration of HITECH Act funding, makes it look less like a startup and more like an established business. (The agency now has 10 offices instead of 17.)

One doesn't reach the "established business" phase without succeeding – and, for its faults, the ONC and meaningful use have succeeded in getting providers to use electronic records. The aforementioned CDC report notes that EHR use more than doubled between 2007 (35 percent) and 2012 (72 percent) and has quadrupled since 2001 (18 percent). In addition, research from SK&A shows that small medical offices are using EHR systems, in part because an increasing number of vendors offer software for small and even solo practitioners.

What's more, for all the frustration surrounding meaningful use stage 2 attestation, there have been some silver linings.

The GAO notes that hospitals attesting for stage 1 hit their goals by an average of more than 10 percentage points. In the case of CPOE, they exceeded the stage 2 requirement for medication orders (60 percent) in their stage 1 attestation (84 percent, on average).

Despite that EHR buyers' remorse, health IT spending isn't slowing down. In particular, organizations want to invest in data analytics to gain insight from the data locked in those EHR systems they may (or may not) regret buying.

Finally, 12 AHRQ grant recipients are researching meaningful use stage 3 feasibility, looking at overall objectives as well as specific measures pertain to patient engagement and data exchange. It's hoped that the results of this research will influence the stage 3 criteria that are in the works.

Healthcare has a long way to go to see the benefits of meaningful use, and it must improve data capture, portability and interoperability if today's EHR systems can play a role in tomorrow's coordinated healthcare systems. Though there's disagreement about whether pausing, refocusing or altogether scrapping meaningful use will accomplish this, the fact that the conversation is happening at all suggests that the incentive program's legacy will be more than the dollars that it gave healthcare providers.